NEW YORK – Roche this week announced that its Elecsys Neurofilament Light Chain test for Multiple Sclerosis has received breakthrough device designation from the US Food and Drug Administration. The minimally invasive test is intended as an aid for the detection of disease activity in adults ages 18 to 55 with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis, the company said in a statement.
Accelerate Diagnostics this week announced that its third quarter net sales increased 10 percent year over year to $3.3 million from $3.0 million primarily due to capital equipment sales in the quarter. The Tucson, Arizona-based maker of infectious disease identification and antimicrobial susceptibility testing systems said it placed six Pheno instruments in the quarter and had a total of 339 contracted instruments generating revenue in the US plus 70 systems contracted in the process of being implemented at the end of Q3. It also secured more than 20 existing customers in multi-year contract extensions during the quarter. Accelerate reported net income of $910,000, or $.06 per share, for the three months ended Sept. 30 compared to a net loss of $15.9 million, or $1.83 per share a year ago, according to the firm's form 10-Q filed with the US Securities and Exchange Commission. The firm ended the quarter with $20.2 million in cash and cash equivalents.
Thermo Fisher Scientific’s board of directors this week authorized a quarterly cash dividend of $.35 per share, payable on Jan. 16, 2024, to shareholders of record on Dec. 15.
Oncocyte this week said its third quarter revenues grew to $429,000 from $67,000 a year ago, driven mainly by an increase in its pharma services revenues. It beat the consensus Wall Street estimate of $330,000. The Irvine, California-based cancer diagnostics firm had a net loss of $6.5 million, or $.81 per share, for the three months ended Sept. 30 compared to a net loss of $9.3 million, or $1.62 per share, a year ago and beat analysts’ average estimate of a loss of $1.01 per share. It used roughly 8.3 million shares to calculate its loss per share figure in the recently completed quarter compared to 5.9 million shares a year ago. Oncocyte's R&D spending rose 47 percent to $2.2 million from $1.5 million a year ago, while its SG&A costs were almost halved to $3.2 million from $6.1 million. It finished Q3 2023 with $13.8 million in cash and cash equivalents and $441,000 in marketable equity securities.
Unilabs this week announced it has completed its acquisition of laboratory diagnostics and thrombosis care provider Atalmedial. The deal significantly enhances Unilab's network of specialized diagnostic labs in the Netherlands, it said. Unilabs is based in Geneva and has locations throughout Europe. Terms of the purchase were not disclosed.
MDxHealth this week reported its third quarter revenues rose 73 percent year over year, to $19.3 million from $11.2 million one year earlier, which includes $8.1 million from its Genomic Prostate Score test, $6.6 million from its post-biopsy Confirm MDx test, $2.7 million from its Resolve MDx urinary tract infection test, and $1.9 million from its Select MDx urine-based liquid biopsy. The Irvine, California-based firm said it had a net loss of $10.0 million for Q3, or $.04 per share, compared to a loss of $13.5 million, or $.08 per share, in the prior-year quarter. The company expects full-year revenues at the high end of its guidance of $65 million to $70 million, and it expects to become profitable on an adjusted basis in the first half of 2025. MDxHealth ended the quarter with $32.7 million in cash and cash equivalents.
Co-Diagnostics this week reported its third quarter revenues dropped 51 percent to $2.5 million from $5.1 million a year ago. For the three months ended Sept. 30, product revenues declined to $136,533 from $5.1 million in Q3 2022 as demand for COVID-19 tests plummeted. Grant revenues, meanwhile, rose to $2.3 million from none a year ago. The firm's net loss rose to $6.0 million, or $.20 per share, from $1.4 million, or $.04 per share, a year ago. Its R&D costs grew to $5.8 million from $5.0 a year ago, while its SG&A costs declined to $5.1 million from $5.5 million. Co-Diagnostics finished Q3 2023 with $10.2 million in cash and cash equivalents and $53.2 million in marketable investment securities.
Swedish cancer testing firm Immunovia this week reported interim net sales for the three months ended Sept. 30 of SEK 488,000 ($45,000), up from SEK 358,000 a year ago. The firm had a net loss of SEK 38.6 million, or SEK .91 per share, compared to a net loss of SEK 22.9 million, or SEK 1.01 per share, a year ago. Immunovia, which is restructuring its operations, exited the quarter with SEK 107 million in cash and cash equivalents.
Devyser this week reported its third quarter revenues rose 50 percent to SEK 46.7 million ($4.3 million) from SEK 31.2 million a year ago. During the quarter, the firm received IVDR certification for its test for detecting donor-derived cell-free DNA in blood samples from kidney transplant patients, as well as for its product for the follow-up care of stem cell patients. Also, the company and Thermo Fisher Scientific agreed to expand their collaboration, which previously covered North America and Europe, to include Brazil in a deal to distribute Devyser's transplant products. Additionally, the two firms agreed to market Devyser's technologies to CLIA-certified labs. The company had a post-tax loss of SEK 6.0 million, or SEK .37 per share, compared to a post-tax loss of SEK 8.8 million, or SEK .55 per share, a year ago.
South Korean cancer firm Deep Bio said this week that it has joined CancerX, a public-private partnership that is part of the White House Cancer Moonshot program and is aimed at innovating new approaches against cancer. Deep Bio provides in vitro diagnostic software powered by deep-learning algorithms as a medical device. According to the firm, the software improves the accuracy and efficiency of cancer diagnosis, allowing healthcare providers to make better treatment decisions.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.